Wearable system and method for monitoring intoxication

ABSTRACT

A system for transdermal alcohol sensing to be worn near a skin surface of a user, including: an alcohol sensor; a microporous membrane; a housing coupled to the alcohol sensor and the membrane, defining a volume between the alcohol sensor and a first membrane side, and fluidly isolating the volume from a second membrane side opposing the first membrane side; an electronics subsystem electrically coupled to the alcohol sensor, operable to power and receive signals from the alcohol sensor; and a fastener operable to position the second membrane side proximal the skin surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/666,062, filed 1 Aug. 2017, which is a continuation of U.S.application Ser. No. 15/375,801, filed 12 Dec. 2016, now issued as U.S.Pat. No. 9,788,772, which claims the benefit of U.S. ProvisionalApplication No. 62/269,854, filed 18 Dec. 2015, and is acontinuation-in-part of U.S. application Ser. No. 15/294,317, filed on14 Oct. 2016, which is a continuation of U.S. application Ser. No.14/925,675, filed 28 Oct. 2015, which is a continuation of U.S.application Ser. No. 14/631,125, filed 25 Feb. 2015, which is acontinuation-in-part of U.S. application Ser. No. 14/470,376 filed 27Aug. 2014, which is a continuation of U.S. patent application Ser. No.14/169,029, filed 30 Jan. 2014, which claims the benefit of U.S.Provisional Application Ser. No. 61/812,704 filed 16 Apr. 2013 and U.S.Provisional Application Ser. No. 61/759,390 filed 31 Jan. 2013, whichare each incorporated in their entirety herein by this reference.

TECHNICAL FIELD

This invention relates generally to the intoxication monitoring field,and more specifically to a new and useful system and method formonitoring intoxication.

BACKGROUND

Alcohol use remains the third leading cause of death both in the USA(85,000 deaths annually) and worldwide (up to 2.5 million deathsannually). The economic costs associated with excessive drinking exceed$223 billion annually in the USA alone. Some of the objective methodsfor measuring alcohol, such as breathalyzers and biological assays, canhave significant drawbacks, such as invasiveness, constant userinteraction, and/or the inability to provide real-time (or nearreal-time) quantitative measurements of alcohol (e.g., as opposed tometabolites). Thus, there is a need in the intoxication monitoring fieldto create an improved intoxication monitoring system and method.

This invention creates such a new and useful intoxication monitoringsystem and method.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic diagram of a variation of the system;

FIG. 1B is a schematic diagram of a variation of the electronicssubsystem;

FIG. 2A is a cross-sectional view of the housing, inlet, and sensor of afirst embodiment of the system;

FIG. 2B is a detail cross-sectional view of the inlet of the firstembodiment of the system;

FIGS. 3A and 3B are an exploded view and a cross-sectional view,respectively, of the housing, inlet, and sensor of a second embodimentof the system;

FIGS. 4A-4D are perspective views of a third embodiment of the system;

FIGS. 5A and 5B are perspective views of the third embodiment of thesystem worn by a user;

FIGS. 6A and 6B are a front view and side view, respectively, of a firstexample of a fourth embodiment of the system;

FIGS. 6C-6F are perspective views of the fourth embodiment of the systemworn by a user on various clothing articles;

FIG. 7A is a front view of a first example of a fifth embodiment of thesystem;

FIGS. 7B and 7C are front views of a second and third example,respectively, of the fifth embodiment;

FIG. 7D is a perspective view of four examples of the fifth embodiment,each worn by a user;

FIG. 8A is a front view of a second and third example of the fourthembodiment of the system;

FIG. 8B is a side view of a fourth and fifth example of the fourthembodiment of the system;

FIG. 8C is a perspective view of a portion of a sixth and seventhexample of the fourth embodiment of the system;

FIG. 9A is a perspective view of a sixth embodiment of the systemincluding a color-changing display element;

FIG. 9B is a front view of the sixth embodiment, displaying fourdifferent colors;

FIGS. 10A and 10B are a perspective view and a side view, respectively,of a seventh embodiment of the system;

FIGS. 10C and 10D are each a perspective view of the seventh embodimentof the system adhered to a user;

FIGS. 11A and 11B are a partial top view and a perspective view,respectively, of an eighth embodiment of the system;

FIGS. 11C and 11D are side views of the eighth embodiment in twofastened conformations, configured to encircle a larger and smallerwrist, respectively;

FIGS. 12A and 12B are a top view and a perspective view, respectively,of a ninth embodiment of the system;

FIG. 12C is a perspective view of a replaceable portion of the ninthembodiment;

FIG. 13 is a perspective view of a tenth embodiment of the system;

FIGS. 14A and 14B are perspective views of a first example of aneleventh embodiment of the system;

FIG. 14C is a perspective view of a second example of the eleventhembodiment;

FIGS. 14D and 14E are a top view and a side view, respectively, of athird example of the eleventh embodiment;

FIG. 15A is a perspective view of an example of a twelfth embodiment ofthe system worn by a user;

FIGS. 15B and 15C are perspective views of two examples of the twelfthembodiment;

FIG. 16 is a perspective view of a thirteenth embodiment of the system;

FIGS. 17-26 and 27A-27B are diagrams of various embodiments of themethod;

FIGS. 28A-28C are a first exploded view, a second exploded view, and across-sectional view of a first example of a fourteenth embodiment ofthe system; and

FIGS. 29A-29C are a first exploded view, a second exploded view, and across-sectional view of a second example of a fourteenth embodiment ofthe system.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiments of the inventionis not intended to limit the invention to these preferred embodiments,but rather to enable any person skilled in the art to make and use thisinvention.

1. Overview.

As shown in FIG. 1A, a system 100 for monitoring intoxication of a user10 preferably includes: a housing 110, an inlet 120, a sensor 130, afastener 140, and an electronics subsystem 150. The system 100 canfunction to enable transdermal measurements of the user's blood alcoholcontent by sensing alcohol (i.e., ethanol) near a user's skin,preferably continuously and in near real time. Transdermal alcoholdetection, which measures alcohol permeating through the skin andcorrelates that measurement to the blood alcohol concentration, canoffer the capacity to provide a noninvasive, continuous, andquantitative measurement of bodily alcohol.

The system 100 can be configured to implement or facilitateimplementation of one or more of the methods described in Section 3below. Additionally or alternatively, the system 100 can be configuredto implement any other suitable method, some embodiments, variations,and examples of which are described in U.S. application Ser. No.15/294,317 filed on 14 Oct. 2016, U.S. application Ser. No. 14/470,376filed 27 Aug. 2014, U.S. application Ser. No. 14/602,919, and U.S.application Ser. No. 15/205,876, which are each incorporated herein intheir entireties by this reference.

2. System. 2.1 Housing.

The housing 110 functions to retain and/or protect the system components(e.g., as shown in FIGS. 7A and 15B-15C) and to position the sensingcomponents (e.g., inlet 120, sensor 130) relative to each other and theuser. The housing 110 is preferably rigid (e.g., made of or including arigid polymer, metal, and/or other rigid material), but canalternatively be partially or entirely flexible. The housing 110 caninclude a low allergic response material (e.g., at a surface configuredto contact the skin of the user, to minimize allergic reactions causedby wearing the system 100). The housing 110 materials can be opaque,transparent, and/or translucent (e.g., to allow viewing of internalcomponents, to enable conduction of light transmitted by systemcomponents, etc.).

The housing 110 can define an analysis volume 111, preferably a sealedanalysis volume (e.g., wherein the volume is fluidly isolated from theambient environment and/or from an outer side 122 of the inlet, etc.)but alternatively a volume open to the ambient environment (e.g.,through the inlet 120, through an outlet, such as an outlet opposing theinlet 120 or in any other suitable position, etc.). In a firstembodiment (e.g., as shown in FIG. 2A), the housing 110 defines acavity, retains the sensor 130 within the cavity, and retains the inlet120 at or near the opening of the cavity, preferably such that the inlet120 is the only (or substantially only) fluidic path into the cavityfrom the ambient environment. The cavity can be defined by a piece(e.g., the housing 110, a portion of the housing 110, etc.) of unitaryconstruction (e.g., wherein the inlet 120 is sealed to the piece, orwherein the inlet 120 and the piece are of unitary construction, etc.),or can be defined by multiple sealed or otherwise physically coextensivepieces (e.g., a first piece, such as a barrel, retaining the inlet 120,sealed to a second piece, such as a cap, retaining the sensor 130; afirst piece retaining both the inlet 120 and sensor 130 sealed by asecond piece; etc.). In a first variation of this embodiment, thehousing 110 retains the inlet 120 and sensor 130 apart from each otherin position (e.g., the sensor 130 retained within the housing 110, andthe inlet 120 adhered to the housing exterior), and can thereby definean analysis volume 111 between the sensor 130 and an inner side 121 ofthe inlet. In a second variation, the inlet 120 is retained against thesensor 130 (e.g., adhered to the sensor 130, pressed against the sensor130 by the housing 110, positioned at the sensor 130 by the housing 110,etc.). In variations, the analysis volume 111 can have a volume from 0.1μL to 10 mL. Alternatively, the analysis volume 111 can be substantiallyzero (e.g., wherein the inlet 120 directly contacts the sensor 130).

The housing 110 can additionally or alternatively be operable to definea sampling volume 112 between the user 10 (e.g., a skin surface 11 ofthe user 10) and the inlet 120. The sampling volume 112 is preferablyfluidly isolated from the analysis volume, and can additionally oralternatively be fluidly isolated from or fluidly coupled to the ambientenvironment (e.g., when the housing 110 is fastened to or otherwiseretained against the skin surface 11). In variations, the samplingvolume 112 can have a volume from 0.1 μL to 10 mL. Furthermore, theelements of the system 100 can have any suitable morphology thatimproves function of sensing functions of the sensor 130, as describedbelow. For instance, the analysis volume 111 and/or sampling volume 112can have a morphology that drives a sample from the user's skin towardthe sensor 130 (e.g., from the skin toward the inlet 120, through theinlet 120, from the inlet 120 toward the sensor 130, etc.). In examples,the morphology can include a tapered portion (e.g., conical, arcuate,stepped, etc.; wherein the volume narrows toward the sensor), fluidicchannels (e.g., urging fluid movement through the channels), elementsthat promote directed fluid flow due to pressure and/or thermalgradients (e.g., a thermal gradient created by heat from the user),and/or any other suitable elements. Additionally or alternatively, thesystem can include one or more active elements, such as pumps and/orfans, that drive the sample from the user's skin toward the sensor 130.However, the sensor 130 can additionally or alternatively be retained inposition relative to the inlet 120 in any other suitable manner, and/orthe analysis volume can be configured in any other suitable manner.

In one embodiment, the system 100 (e.g., the housing 110, the inlet 120,etc.) includes a gasket 113 arranged to contact (and preferably form aseal with) the skin surface 11 when the system 100 is worn (e.g., gasket113 attached to a broad face of the housing 110 and surrounding theinlet 120). For example (e.g., as shown in FIGS. 3A-B and 4A-D), thegasket 113 can oppose the analysis volume across the inlet 120 (e.g.,across a microporous membrane of the inlet, proximal the outer side 122of the inlet), and the fastener 140 can be configured to retain thegasket 113 against the skin surface 11. In a first variation of thisembodiment, the gasket 113 is operable to seal the sampling volume(cooperatively with the skin surface 11). In a second variation, thegasket 113 includes one or more vents/outlets, which function to enableair circulation within the sampling volume (e.g., to promote usercomfort, to enhance sensor function) and/or reduce moistureretention/condensation within the sampling volume. In examples of thisvariation, the vents of the gasket 113 can be configured about aperipheral region of the gasket and/or configured in any other suitablemanner. However, the housing 110, inlet 120, and/or any other componentof the system can include any other suitable seal located in any othersuitable position, or not include a seal, additional variations of whichare shown in FIGS. 28A-28C and 29A-29C.

The housing 110 can additionally or alternatively retain the othersystem components (e.g., fastener 140, electronics subsystem 150, etc.)within an internal volume of the housing 110, and/or relative to theuser. The components can be retained within the housing 110, can beretained external to the housing, or can additionally or alternativelybe partially retained within the housing. In one variation, one or moreelements can be retained within the housing 110, under a transparentcasing of the housing 110 (e.g., to allow a user to view the componentand/or light emitted by the component, such as a display, light emittingdiode, or other indicator), at an exterior surface of the housing 110(e.g., to allow physical contact with the component, such as anelectrical power and/or data connector or a touch-sensitive control; toallow a user to view the component and/or light emitted by thecomponent; etc.), attached (and/or attachable) to the housing 110,and/or retained in any other suitable arrangement. Additionally oralternatively, one or more portions of the housing 110 can besubstantially opaque, such that elements within the housing are notvisible from outside of the housing 110.

The housing 110 can additionally or alternatively function to maintainsensor environment conditions. For example, the housing 110 can includea thermally insulating material (e.g., to minimize temperature changesof the sensor 130), a water-absorptive element (e.g., to minimize waterinteraction with the sensor 130), and/or any other suitableenvironmental control. However, the housing 110 can additionally oralternatively have any other suitable configuration and include anyother suitable elements.

2.2 Inlet.

The inlet 120 preferably functions to allow controlled ingress of one ormore analytes from the user's body, such as ethanol, toward the sensor130 (e.g., to the sensor 130, to the analysis volume 111, etc.), and canadditionally or alternatively function to prevent contaminant ingresstoward the sensor 130 and/or control (e.g., promote, prevent, etc.)water uptake by the sensor 130. The inlet 120 preferably defines anouter side 121 (e.g., ambient environment and/or sampling volume side)and an inner side 122 (e.g., analysis volume side) opposing the outerside 121 across the inlet 120. The inlet 120 can cooperate with one ormore apertures 123 (e.g., includes a barrier layer defining anaperture), which function to allow or otherwise control sample ingress,through the inlet 120 into the analysis volume and towards the sensor130, and one or more membranes 124, which function to minimizeobstruction of the aperture(s) 123 and/or prevent ingress of solids,liquids, and/or undesired vapors.

The aperture 123 is preferably formed by removing material (e.g.,laser-drilling, milling, etching, or otherwise removing material from anelement such as a barrier layer), but can additionally or alternativelybe formed by joining pieces (e.g., joining two pieces with semicirculargaps along an edge, etc.) or in any other suitable way. In variationsthat include a barrier layer defining the aperture 123, the barrierlayer is preferably made of a rigid material (e.g., metal such asstainless steel, rigid polymer, etc.), but can additionally oralternatively include any other suitable material. In variations, theaperture 123 can be defined through a surface of the housing 110;however, the aperture 123 can additionally or alternatively be definedby any other element(s) of the system 100. In alternative examples, theaperture 123 can be a single hole, an array of holes, a screen, a porousbarrier (e.g., microporous barrier), a diffusive barrier (e.g., materialallowing diffusion of the analyte and/or other species across thebarrier, such as silicone), and/or any other suitable aperture 123configured to limit the ingress of the analyte and/or other species.Furthermore, the aperture(s) can have a fixed opening size, or canalternatively be adjustable in size to control the amount of sampleentering the system for analysis.

The aperture 123 preferably limits the rate of analyte (and/or otherspecies) ingress toward the sensor 130, which can function to minimizespurious signals due to changing user perspiration rates (e.g., due toexertion) and/or system movement (e.g., with respect to the skin surface11). The aperture cross-sectional dimensions (e.g., diameter of acircular aperture, side, diagonal length of a rectangular aperture,etc.) are preferably micron-scale (e.g., 0.01 mm, 0.025 mm, 0.05 mm, 0.1mm, 0.2 mm, 0.3 mm, 0.5 mm, 0.05-0.1 mm, 0.03-0.2 mm, etc.), but canalternatively be larger (e.g., 1 mm, 2 mm, greater than 1 mm, etc.) orsmaller. A micron-scale aperture can help limit ethanol ingress to anappropriate rate for the sensor 130.

Each membrane 124 is preferably a microporous membrane (e.g.,microporous polytetrafluoroethylene membrane). Each of the membranes 124is preferably vapor-permeable, and can be permeable to ethanol vapor(and/or vapor of any other suitable analyte). Furthermore, each of themembranes is preferably impermeable to liquids and solids; however,variations of the membranes can alternatively allow some materialingress. For instance, the membrane 124 can be impermeable or permeableto water. The membranes 124 can be hydrophilic or hydrophobic.

Each membrane 124 preferably covers the aperture 123 (e.g., is attachedto the barrier layer surrounding the aperture 123). The inlet 120 caninclude one membrane 124 covering the outer 121 or inner side 122 of theaperture, two membranes 124 (e.g., one covering each of the aperturesides, as shown in FIG. 2B), or any other suitable number of membranes124 in any other suitable arrangement. In variations that include amembrane 124 covering the inner side 122 (“inner membrane”, 124 a), thehousing 110 (and/or other suitable component of the system) preferablyfluidly isolates the entire inner membrane from the ambient environmentand/or sampling volume 112, except for a possible fluidic path throughthe aperture 123 (e.g., to prevent the analyte and/or other species fromreaching the analysis volume 111 without passing through the aperture123, such as by lateral transit through the inner membrane beginningfrom an exposed edge of the inner membrane). Analogously, a membrane 124covering the outer side 121 (“outer membrane”, 124 b) is preferablyfluidly isolated from the analysis volume 111, except for a possiblefluidic path through the aperture 123.

In one embodiment, at least one of the membranes 124 is adhesive (orincludes an adhesive layer), and the inlet 120 is retained by theadhesive membrane (e.g., adhesive microporous polytetrafluoroethylenemembrane). The adhesive membrane can be easily removable and/orreplaceable by a user (e.g., allowing user replacement of themembrane(s) 124, the aperture 123, and/or any other elements of theinlet 120 and sensor 130), or can additionally or alternatively bedesigned to be replaced by a vendor when needed. In a first variation ofthis embodiment, the membrane 124 is adhered to the housing 110 (e.g.,to a rim surrounding a cavity defined by the housing 110, to a lipwithin the cavity, to the inner sidewalls of the cavity, etc.). In asecond variation, the membrane 124 is adhered to the sensor 130 (e.g.,to a broad face of the primary wafer 131, preferably the face proximalthe counter electrode 133). In a first example of this variation, themembrane 124 is adhered directly to the sensor 130. In a second example,a spacer (e.g., washer, standoff, etc.) is adhered to the sensor 130,and the membrane 124 is adhered to the spacer. The spacer can functionto prevent mechanical damage of the inlet 120 and/or sensor 130 arisingfrom direct contact (e.g., prevent an electrode such as the counterelectrode 133 from puncturing the membrane 124). In examples including aspacer, the spacer can be made of or include a polymer, such aspolypropylene, but can additionally or alternatively include metal,ceramic, and/or any other suitable material.

However, one or more membranes 124 can additionally or alternatively bearranged within the aperture 123 (e.g., filling the aperture 123partially or entirely), or can have any other suitable arrangement withrespect to the aperture 123 and other system elements.

2.3 Sensor.

The sensor 130 functions to sample the concentration of one or moreanalytes. The sensor 130 is preferably operable to detect alcohol (i.e.,ethanol), but can additionally or alternatively be operable to detectany other suitable analyte. The analyte is preferably emitted by theuser 10, but can additionally or alternatively come from any othersuitable source. The sensor 130 is preferably arranged within thehousing 110, as described in Section 2.1 above, and the analytepreferably travels from the user 10 to the sensor 130 through the inlet120 (e.g., as described above). However, the sensor 130 can have anysuitable arrangement.

The sensor 130 preferably includes a fuel cell configured to facilitateand/or quantify chemical reactions involving the analyte (e.g., as shownin FIG. 2A). The fuel cell can have three electrodes (e.g., a counterelectrode 133 and a sensing electrode 134 configured to conduct andallow detection of current generated by the fuel cell, and a referenceelectrode 135 configured to provide a reference potential) butalternatively can be a two-electrode fuel cell (e.g., not include areference electrode) or have any other suitable number of electrodes.

The fuel cell preferably includes a primary wafer 131 (e.g., throughwhich protons can diffuse or be otherwise transported) or other fuelcell element configured to transport protons and/or other products of areaction involving the analyte. The fuel cell preferably includes asingle primary wafer 131 to which both the counter electrode 133 and thesensing electrode 134 are electrically connected or otherwiseelectrically coupled (e.g., to opposing sides of the primary wafer 131),but can alternatively include multiple primary wafers 131 (e.g., whereinthe counter electrode 133 is electrically connected to a first side of afirst primary wafer, the sensing electrode 134 is electrically connectedto a first side of a second primary wafer, and the second sides of thetwo wafers are electrically connected to each other) or any othersuitable reaction product transport elements. One or more of the sidesof the primary wafer(s) 131 (e.g., the sides to which fuel cellelectrodes are connected) preferably include a catalytic coating orother catalyst configured to catalyze the fuel cell reactions. The fuelcell electrodes can additionally or alternatively include or be made ofa catalyst. The wafer and/or electrode catalyst preferably includesplatinum, but can additionally or alternatively include any othersuitable catalytic agent.

The fuel cell preferably includes one or more reservoir wafers 132. Thereservoir wafer 132 can retain species involved in the fuel cellreactions (e.g., water), contaminants (e.g., unwanted species that enterthe analysis volume 111 through the inlet 120), and/or any othersuitable species. Alternative system configurations can include a liquidand/or vapor reservoir 136 configured to retain these species, and canadditionally include sealing elements to minimize egress of the speciesfrom the reservoir 136, or otherwise promote a hydrated state of thereservoir 136. In fuel cells including a reservoir 136, the reservoir136 is preferably fluidly coupled to one or more of the primary wafersurfaces (e.g., so that water can flow between the reservoir 136 and thesurfaces). In one example, the reservoir 136 is arranged opposing theanalysis volume 111 and/or inlet 120 across the primary wafer 131 (e.g.,such that the primary wafer 131 directly contacts the reservoir 136). Ina second example, the reservoir 136 is arranged apart from the primarywafer 131, and is fluidly coupled to the primary wafer 131 by one ormore tubes, channels, and/or other fluid pathways (e.g., defined by thehousing 110). In variations, the reservoir 136 can have a volume from0.1 μL to 10 mL. However, the reservoir 136 can have any other suitablesize, shape, and/or arrangement.

In one embodiment, as shown in FIG. 2A, the fuel cell includes a counterelectrode 133 electrically coupled to a catalytic coating on a firstside of a primary wafer 131, and a sensing electrode 134 electricallycoupled to a catalytic coating on a second side of the primary wafer 131opposing the first side. The counter electrode 133 is preferablymaintained at a positive potential relative to the sensing electrode134, but can alternatively be maintained at any suitable potential, ornot be maintained at a specific potential. Ethanol incident upon thesecond side reacts (e.g., catalyzed by a catalytic coating) with water(e.g., from the counter-reaction, from the reservoir wafer 132, fromair, etc.), producing ethanoic acid, protons, and electrons (e.g., asdescribed by the chemical reaction CH₃CH₂OH+H₂O→CH₃COOH+4e⁻+4H⁺). Thegenerated protons travel through the primary wafer 131 to the firstside, while the generated electrons travel from the sensing electrode134, through a current sensor (e.g., circuit operable to quantifyelectrical current), to the counter electrode 133. At the first side, acounter-reaction occurs: the protons and electrons react (e.g.,catalyzed by a catalytic coating) with oxygen (e.g., from air, such asair from the ambient environment and/or sampling volume 112 that travelsthrough the inlet 120 to the sensor 130) to produce water (e.g., asdescribed by the chemical reaction O₂+4H⁺+4e^(−→)2H₂O). The currentsensor samples the current generated by the fuel cell, which is directlyproportional to the amount of ethanol reacting at the fuel cell (and cantherefore be correlated with the amount of transdermal ethanol reachingthe sensor 130). The electrodes and catalytic coatings are preferablymade of platinum, but can additionally or alternatively include anyother suitable materials.

In a first variation of this embodiment, the fuel cell additionallyincludes a reference electrode 135 (e.g., platinum reference electrode).In this variation, the electric potential of the sensing electrode 134can be maintained relative to the reference electrode 135 (e.g.,maintained at a predetermined potential difference, such as 0 V, −0.1 V,−0.5 V, +0.25 V, etc.; maintained at a dynamically determined potentialdifference). This variation can enable a passive, noninvasive, and/orcontinuous measurement of transdermal alcohol, and can provide enhancedsampling speed, signal stability, and/or sensor longevity. In a secondvariation, the system includes a two-electrode fuel cell, an outletthrough which the analyte can exit the analysis volume 111, and a pumpoperable to move the analyte through the analysis volume 111 and out theoutlet. However, the fuel cell can include any suitable elements in anysuitable arrangement.

Additionally or alternatively, the sensor 130 can include a sensorconfigured to detect resistance changes (e.g., of a silicon oxide or tinoxide sensor element) in response to the presence of alcohol vapor (orany other suitable analyte), and/or include any other suitable mechanismfor detecting the analyte concentration.

2.4 Electronics Subsystem.

The electronics subsystem 150 preferably functions to power and controlthe sensor 130 and to receive, analyze, store, and/or transmit datasampled by the sensor 130. The electronics subsystem 150 preferablyincludes a processor 151 and a power module 152, and can additionally oralternatively include a communication module 153, display 154, lightemitter 155, and/or any other suitable elements (e.g., as shown in FIG.1B).

The processor 151 is preferably operable to continuously determine atime series of blood alcohol contents of the user based on a time seriesof signals received from the alcohol sensor. The samples can becollected automatically and/or manually, can be collected continuouslyand/or intermittently, and can be collected at regular and/or irregularintervals. The processor 151 can control system components to reducesystem power consumption. For example, the processor 151 can alter therate at which the sensor 130 samples the alcohol concentration (e.g.,based on current and/or previous sensor data; user inputs; auxiliaryinformation such as user location, user preferences, user history,etc.). In a specific example, when the sensor 130 indicatessubstantially no alcohol presence, the processor 151 can control thesensor 130 to reduce the sampling rate (e.g., to once every 0.5, 1, 2,3, 5, 10, 20, 1-5, or 3-10 minutes). In this specific example, whenalcohol is detected, the processor 151 can control the sensor 130 toincrease the sampling rate (e.g., to sample as quickly as possible; tosample once every 0.1, 0.5, 1, 2, 3, 5, or 0.5-2 seconds). As such, theprocessor 151 can be operable to dynamically modulate a sampling rateassociated with the sensor. However, the processor 151 can additionallyor alternatively be operable in any other suitable way.

While aspects of the processor 151 are preferably implemented, at leastin part, at the wearable device described above, one or more modules ofthe processor 151 can additionally or alternatively be implemented inone or more processing elements (e.g., hardware processing element,cloud-based processing element, etc.) not physically integrated with thewearable device, such that processing by the system 100 can beimplemented in multiple locations and/or phases.

The power module 152 can function to power the processor 151, sensor130, and/or any other suitable components of the system. The powermodule is preferably electrically coupled (e.g., connected by conductivewire) to the processor 151, sensor 130, and/or other powered systemcomponents, wherein the processor preferably controls power provision(e.g., through component operation mode control), but power provisionand/or power module management can alternatively be performed by anyother suitable component.

The power module 152 preferably includes a power source. The powersource preferably includes a battery, and in variations can include oneor more of a primary battery and a secondary battery. The power module152 can additionally or alternatively include a capacitor (e.g., tofacilitate fast discharging in combination with a battery), a fuel cellwith a fuel source (e.g., metal hydride), a thermal energy converter(e.g., thermionic converter, thermoelectric converter, mechanical heatengine, etc.) optionally with a heat source (e.g., radioactive material,fuel and burner, etc.), a mechanical energy converter (e.g., vibrationalenergy harvester), a solar energy converter, and/or any other suitablepower source. In variations of a power source 152 including a battery,the battery can have a lithium phosphate chemistry, lithium ion polymerchemistry, lithium ion chemistry, nickel metal hydride chemistry, leadacid chemistry, nickel cadmium chemistry, metal hydride chemistry,nickel manganese cobalt chemistry, magnesium chemistry, or any othersuitable chemistry. The primary battery can have a lithium thionylchloride chemistry, zinc-carbon chemistry, zinc chloride chemistry,alkaline chemistry, oxy nickel hydroxide chemistry, lithium-irondisulfide chemistry, lithium-manganese oxide chemistry, zinc-airchemistry, silver oxide chemistry, or any other suitable chemistry.

The power module 152 can additionally or alternatively include a powerinput. The power input preferably includes an electrical connector(e.g., jack, plug, etc.), but can additionally or alternatively includea wireless electrical power input (e.g., inductive power input) and/orany other suitable power input. The electrical jack is preferablyelectrically coupled to the battery, processor 151, and/or any othersuitable component of the electronics subsystem, more preferablyoperable to receive an electrical power input and to transmit theelectrical power input to the electronics subsystem. In a specificexample, the electrical jack is retained at a surface of the housing110, wherein the electrical jack is partially or entirely covered by theuser 10 during normal wear of the system (e.g., the electrical jack islocated on the same side of the housing as the inlet 120).

The communication module can function to communicate with externaldevices, such as a user device or remote computing system. Thecommunication module can include a wireless communication module (e.g.,radio) and/or a wired communication module. The wireless communicationmodule can support one or more short-, medium-, and/or long-rangecommunication protocols, such as cellular, WiFi, Bluetooth, BLE, NFC,and/or any other suitable wireless communication protocols. The wiredcommunication module preferably includes an electrical connection and/orconnector (e.g., USB, Ethernet, coaxial, etc.) configured to transmitdata. In one example, the electrical connection is a wired connection toa wearable device 200 (e.g., through a fastener 140 coupled to thewearable device 200). In another example, the electrical connection is awireless connection (e.g., Bluetooth LE connection) that allows forcommunication between the system 100 and another computing system (e.g.,mobile computing device, personal computer, etc.).

The communication module can send information (e.g., sensormeasurements, system status, etc.) and/or control instructions to theexternal devices, and/or can receive information and/or controlinstructions (e.g., configuration information such as user preferences,requests for sensor measurements, etc.) from the external devices. Forexample, the processor can be operable to control a user device such asa smartphone or wearable device 200 (e.g., forearm-mountable computingdevice) to provide an intoxication notification based on the time seriesof blood alcohol contents (e.g., sampled by and received from the sensor130).

The display and/or light emitter can function to display sensormeasurements (e.g., numeric value of user's blood alcohol content;indication of the blood alcohol content range, such as high, low, ornone; etc.), system status (e.g., normal status, sensor malfunction, lowbattery, etc.), messages for the user 10 (e.g., motivational messages),and/or any other suitable information. For example, the light emittercan emit green light when no alcohol is detected, yellow when moderateamounts of alcohol are detected, and red when high amounts of alcoholare detected. However, the electronics subsystem 150 can include anyother suitable elements, and perform any other suitable functions, someembodiments, variations, and examples of which are described in U.S.application Ser. No. 15/294,317 filed on 14 Oct. 2016, U.S. applicationSer. No. 14/470,376 filed 27 Aug. 2014, U.S. application Ser. No.14/602,919, and U.S. application Ser. No. 15/205,876, which are eachincorporated herein in their entireties by this reference.

2.5 Fastener.

The fastener 140 functions to couple the system 100 to a user. Thefastener 140 and housing 110 can be of unitary construction or otherwisephysically coextensive, or can be otherwise connected, coupled, orcouplable.

The fastener 140 is preferably operable to retain the outer side 121 ofthe inlet against or near a skin surface 11 of the user. For example,the fastener 140 can be coupled to the housing 110 and operable toposition a microporous membrane 124 (e.g., outer side of the outermembrane) proximal the skin surface 11 (e.g., retaining the membrane 124against the skin surface 11, retaining a nearby gasket 113 or face ofthe housing against the skin surface 11, etc.). In embodiments thatinclude an electrical jack near the inlet 120 (e.g., both on the samebroad face of the housing 110), the fastener 140 can be furtherconfigured to position the electrical jack proximal the skin surface.

The fastener 140 is preferably operably to be easily and/or repeatablyfastened and unfastened manually by the user 10. In specific examples,the fastener 140 can include a latch, snap, buckle, clasp, hook-and-loopfastening mechanism, and/or any other suitable fastening mechanism,and/or can be operable to expand and contract (e.g., including anelastic element, such as an expansion band; including a deploymentclasp, butterfly clasp, or other clasp that is physically coextensivewhen unclasped; etc.). Alternatively, the fastener 140 can require a keyor other security mechanism to be fastened and/or unfastened, can have atamper-evident fastening mechanism (e.g., wherein the fastener 140 ischanged during unfastening, such that it has a different visualappearance upon refastening), and/or can include any other suitablesecurity elements.

In a first embodiment, the fastener 140 includes a strap (or straps)operable to encircle a body part of the user, such as the wrist and/orforearm (e.g., as shown in FIGS. 5A-5B, 7B-7C, 9A-9B, 11A-11D, 12A-12C,and 15A). In this embodiment, the strap(s) can retain the inlet 120 nearor against a skin surface 11 (e.g., skin surface 11 on the same bodypart or a nearby body part of the user). The straps are preferablyconnected to the housing 110 on or proximal opposing edges of thehousing (e.g., a top edge and a bottom edge).

In a first variation of this embodiment, the fastener 140 and housing110 are operable to cooperatively encircle the entire body part. In afirst example of this variation, the fastener 140 includes two straps,each connected (e.g., at or near a first end of the strap) to thehousing 110 proximal one edge of the housing, and operable to connect toeach other (e.g., by a buckle, claw clasp, jewelry clasp, etc.; at ornear a second end of the strap opposing the first end) to encircle thebody part. In a second example, the fastener 140 includes a single strap(e.g., each end of the strap connected to one of the opposing edges ofthe housing), and the strap is operable to expand and contract (e.g., asdescribed above).

In a second variation of this embodiment, the fastener 140 is operableto couple to (e.g., connect to) a wearable device 200 such as aforearm-mountable computing device and/or wristwatch (e.g., serving asthe strap(s) of the watch or computing device), and when coupled, beoperable to cooperatively encircle the entire body part with the housing110 and the wearable device 200. In a first example of this variation,the sensor 130, electronics subsystem 150, and/or other systemcomponents can communicate with and/or receive power from (or send powerto) the wearable device 200 through the fastener 140 (e.g., through anelectrical connection in the strap). In a second example, the sensor130, electronics subsystem 150, and/or other system components areelectrically isolated from the computing device.

In a second embodiment, the fastener 140 is operable to retain thehousing 110 on or within a wearable device 200 such as a wristwatch orforearm-mountable computing device. The inlet 120 is preferably retainedon or proximal the skin surface 11 by the wearable device 200. In thisembodiment, the fastener 140 can be removably and/or repeatablycouplable to the wearable device 200, or can be substantiallypermanently coupled or couplable to the wearable device 200 (e.g., noteasily uncoupled and/or recoupled by a user).

In a first variation of this embodiment, the housing 110 fits within acavity 210 defined by the wearable device 200 (e.g., as shown in FIG.16). The sensor 130, electronics subsystem 150, and/or other systemcomponents are preferably operable to communicate with and/or receivepower from (or send power to) the wearable device 200 (e.g., through anelectrical connection, wirelessly, etc.), but can alternatively notcommunicate with and/or be powered by the wearable device 200. Inexamples of this variation, the fastener 140 can be operable to coupleto the wearable device 200 by a latch (e.g., fastened by pressing thesystem 100 into the cavity 210 of the wearable device, unfastened bypressing a release button), a bayonet mount, a threaded barrel (e.g.,wherein the fastener 140 includes threading around a cylindrical housingand is operable to screw into complementary threading on the cavity 210of the wearable device), by one or more mechanical fasteners (e.g.,screw, clip, etc.), can be retained by friction, adhesive, and/or vander Waals forces, and/or can be otherwise coupled or coupleable.

In a second variation of this embodiment, the fastener 140 attaches to astrap 220 or other fastening element of the wearable device 200 (e.g.,as shown in FIGS. 14A-14E). For example, the housing 110 and fastener140 can cooperatively encircle a strap 220 of the wearable device 200.

In a third embodiment, the fastener 140 attaches or is operable toattach the system 100 to a clothing article 12 (e.g., as shown in FIGS.6A-6F, 7D, and 8A-8C). In this embodiment, the inlet 120 is retained onor proximal the skin surface 11 by the clothing article 12. In a firstvariation of this embodiment, the fastener 140 includes a clip operableto fasten near an edge of the clothing article 12 (e.g., to a waistband;bra strap, band, bridge, or cup; sock cuff; etc.). In a secondvariation, the housing 110 (e.g., a back side of the housing opposingthe inlet 120) is attached to (e.g., adhered to, fused or sewn into,etc.) an interior surface of the clothing article 12.

In a fourth embodiment, the fastener 140 is operable to mount the system100 directly to the user's skin (e.g., as shown in FIGS. 10A-10D). Thefastener 140 preferably mounts the system 100 on, around, and/or nearthe skin surface 11 and preferably positions the inlet 120 on or nearthe skin surface 11. In variations of this embodiment, the fastener 140can include an adhesive layer, a suction mount, a mount attachable byvan der Waals forces, and/or any other suitable surface mount. However,the fastener 140 can include any other suitable mechanism for couplingthe housing 110 to the user 10.

The fastener 140 (and/or housing 110) can include a display facilitatingelement that functions to allow a user to view information provided byone or more displays/light indicators of the system 100 (e.g., as shownin FIG. 13). For example, the fastener 140 and/or housing 110 caninclude a translucent region optically coupled to a light emitter (e.g.,retained at or near a surface of the housing, such as near a connectionbetween the fastener 140 and the housing 110) and operable to conduct alight signal emitted by the light emitter. In a specific example, thelight-emitting element is operable to emit light of several differentcolors, and a translucent region of a strap (e.g., a stripe along thestrap, substantially the entire strap, etc.) glows in the color emittedby the light-emitting element. Such display facilitating elements cancomprise elements and/or be configured in analogous ways to the elementsdescribed in one or more of: U.S. application Ser. No. 15/294,317, filedon 14 Oct. 2016 and U.S. application Ser. No. 14/470,376 filed 27 Aug.2014, which are each incorporated in their entireties herein by thisreference.

2.6 Calibration Element.

The system 100 can additionally or alternatively include one or morecalibration elements. The calibration element can enable systemself-calibration (e.g., by supplying a calibrated concentration ofalcohol, by supplying a known quantity of alcohol, by supplying aquantity of alcohol with a specific time-release profile, etc.). Thecalibration element can be reusable or designed for a singlecalibration. In one embodiment, the calibration element is operable tocover the inlet 120 (e.g., by attaching to the housing 110). Forexample, the calibration element can be an adhesive patch, including acalibrated amount of alcohol, that can be applied to the backside of thehousing 110 over the inlet 120 prior to use of the system 100 by a user.The system 100 can be worn with the calibration patch in place while thecalibration process occurs, after which the calibration patch can beremoved and the system 100 can be worn for normal use. In a secondembodiment, the calibration element includes a chamber (e.g., sealedchamber) into which the system can be placed, and a calibrated alcoholenvironment can be maintained within the chamber.

The calibration element can additionally or alternatively include atemperature sensor configured to be in thermal communication with theuser, by way of the housing and/or the fastener. The temperature sensorcan function to enable temperature-based calibration of the sensor(e.g., adjusting sensor readings based on the measured temperature and atemperature calibration curve, such as a predetermined or dynamicallydetermined calibration curve), and/or to detect when the system 100 isworn (e.g., wherein sustained increased temperature can indicatecontinuous wear, and temperature reduction can indicate removal of thesystem 100). However, the system 100 can include any suitablecalibration elements and/or any other suitable elements.

3. Method.

A method 1 for intoxication monitoring can be performed with atransdermal alcohol sensing system (e.g., the system 100 describedabove). In a first embodiment (e.g., as shown in FIG. 17), the method 1can include determining correlations between alcohol consumption andother health metrics (e.g., sleep quality, weight, exercise, diet, heartrate, blood pressure, hangover symptoms, behavior characteristics, etc.)and presenting data about the other health metrics and/or thecorrelations to a user (e.g., at a user device, at the alcohol sensingsystem). In a second embodiment (e.g., as shown in FIG. 18), the method1 can include determining that a user may consume more alcohol than safeor desired (e.g., at a winery tasting room, at a college party, etc.)and presenting recommendations to the user (e.g., stop drinking at atime that will allow the user to become sober before needing to drive,reduce the rate of drinking to avoid health risks, etc.). In a thirdembodiment (e.g., as shown in FIG. 19), the method 1 can includedetermining correlations between drinking events (e.g., sipping detectedbased on accelerometer data) and blood alcohol content and/or userperformance on intoxication tests (e.g., puzzles, speech clarity, pupildilation), presenting the correlations to the user, and/or preventinguser actions (e.g., placing phone calls or sending text messages topredetermined contacts). In a fourth embodiment (e.g., as shown in FIGS.20-22), the method 1 can include detecting user intoxication (e.g.,through a worn alcohol sensor and/or an alcohol sensor integrated into apiece of equipment, such as a steering wheel of a vehicle or a sensorassociated with an employee time logging system) and, in response todetecting intoxication, providing a warning (e.g., to the user, to asupervisor of the user, etc.) and/or preventing use of the equipment. Ina fifth embodiment (e.g., as shown in FIG. 23), the method 1 can includepresenting a visual indication of a user's ongoing sobriety (e.g., unitsof time such as days, weeks, or years since the user's last drinkingevent; awards associated with sobriety; etc.). In a sixth embodiment(e.g., as shown in FIG. 24), the method 1 can include presenting avisual indication of a user's current intoxication to another person(e.g., bartender) and/or preventing alcohol purchases by intoxicatedusers. In a seventh embodiment (e.g., as shown in FIG. 25), the method 1can include determining a user's current, past, and/or projectedintoxication and/or presenting an indication (e.g, visual indication,such as a numerical value, directed arrow, trendline, etc.) of theintoxication (e.g., to the user, at a wearable electronic device, etc.).In some embodiments, the method 1 can include (e.g., as shown in FIG.26) controlling the sensor to collect data less frequently when frequentreadings are not desired (e.g., when no alcohol is detected) and/orcontrolling the sensor the sensor to collect data more frequently (e.g.,at a maximum sampling rate) when frequent readings are desired (e.g.,when alcohol is detected), which can function to reduce powerconsumption.

However, the method 1 can include any other suitable blocks or steps,some embodiments, variations, and examples of which are described inU.S. application Ser. No. 15/294,317 filed on 14 Oct. 2016, U.S.application Ser. No. 14/470,376 filed 27 Aug. 2014, U.S. applicationSer. No. 14/602,919, and U.S. application Ser. No. 15/205,876, which areeach incorporated herein in their entireties by this reference. Forexample, the system 100 can include an output (e.g., optical output,such as a light emitter or electronic display; audio output; etc.)operable to output a unique signature, and the method 1 can includeacquiring sensor data including a photograph or video displaying theuser 10 wearing the system 100 and including the unique signature (e.g.,in the photograph or video), examples of which are shown in FIGS.27A-27B.

The preferred embodiments include every combination and permutation ofthe various system components and the various method processes.Furthermore, various processes of the preferred method can be embodiedand/or implemented at least in part as a machine configured to receive acomputer-readable medium storing computer-readable instructions. Theinstructions are preferably executed by computer-executable componentspreferably integrated with the system and one or more portions of theelectronics subsystem 150. The computer-readable medium can be stored onany suitable computer readable media such as RAMs, ROMs, flash memory,EEPROMs, optical devices (CD or DVD), hard drives, floppy drives, or anysuitable device. The computer-executable component is preferably ageneral or application specific processing subsystem, but any suitablededicated hardware device or hardware/firmware combination device canadditionally or alternatively execute the instructions.

The FIGURES illustrate the architecture, functionality and operation ofpossible implementations of systems, methods and computer programproducts according to preferred embodiments, example configurations, andvariations thereof. In this regard, each block in the flowchart or blockdiagrams may represent a module, segment, step, or portion of code,which comprises one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the block can occurout of the order noted in the FIGURES. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts, or combinations of special purpose hardware andcomputer instructions.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

We claim:
 1. A system for transdermal alcohol sensing, the systemcomprising: an alcohol sensing device configured to be worn by a userand interface with an alcohol sensor, the alcohol sensing devicecomprising: a housing coupled to the alcohol sensor; a power sourcecoupled to the housing and electrically coupled to the alcohol sensor byway of the housing; and a fastener coupled to the housing and operableto position the alcohol sensor proximal to a skin surface of the user; aprocessing system communicatively coupled to the alcohol sensing device,wherein the processing system is operable to receive a time series ofsignals from the alcohol sensor and continuously determine a time seriesof blood alcohol content (BAC) metrics based on the time series ofsignals; and an electronic display coupled to the processing system,wherein the processing system is operable to control the electronicdisplay based on the time series of BAC metrics.
 2. The system of claim1, wherein the alcohol sensing device further comprises an electronicssubsystem mounted to the housing, wherein the electronics subsystem isconfigured to receive the time series of signals from the alcohol sensorand transmit the time series of signals to the processing system.
 3. Thesystem of claim 2, wherein the processing system further comprises anapplication configured to execute on a mobile device, the mobile devicecomprising the electronic display and separate from the alcohol sensingdevice.
 4. The system of claim 1, wherein the electronic displaydisplays an estimated time point at which the user will reach a state ofsobriety, wherein the estimated time point is determined at theprocessing system based on the time series of BAC metrics.
 5. The systemof claim 4, wherein the electronic display further displays a predictedtemporal profile of the BAC metric for the user over time.
 6. The systemof claim 1, wherein the processing system comprises a first processingsubsystem located at the alcohol sensing device and a second processingsubsystem remotely located from the alcohol sensing device, wherein thesystem further comprises a data link between the first and secondprocessing subsystems, wherein in the event that the BAC metric exceedsa predetermined threshold, the second processing subsystem transmits anotification to the first processing subsystem via the data link.
 7. Thesystem of claim 6, wherein the housing further comprises an indicatorelement, wherein the notification triggers the indicator element totransition from an “off” to an “on” state.
 8. The system of claim 7,wherein the indicator element comprises a vibration motor.
 9. A systemfor transdermal alcohol sensing, the system comprising: an alcoholsensor; a housing coupled to the alcohol sensor; a processing systemoperable to receive signals from the alcohol sensor; a light emitterconnected to the housing, wherein the processing system is operable tocontrol an operation mode of the light emitter; a vibration motorconnected to the housing, wherein the processing system is operable tocontrol an operation mode of the vibration motor; and a fastener coupledto the housing and operable to position the alcohol sensor proximal to askin surface of the user.
 10. The system of claim 9, wherein a firstprocessing subsystem of the processing system is coupled to anelectronic display, wherein the first processing subsystem is operableto determine a value of a blood alcohol content (BAC) metric based onthe signals.
 11. The system of claim 10, wherein the first processingsubsystem is further operable to control the electronic display based onthe value of the BAC metric.
 12. The system of claim 11, wherein thefirst processing subsystem is located remotely from the housing.
 13. Thesystem of claim 10, wherein the electronic display comprises anestimated time point at which the user will reach a state of sobrietybased on the value of the BAC metric.
 14. The system of claim 13,wherein the electronic display further comprises a predicted temporalprofile of the BAC metric for the user over time.
 15. The system ofclaim 10, wherein the processing system further comprises a secondprocessing subsystem, separate from the first processing subsystem, thesecond processing subsystem mounted to the housing, wherein the secondprocessing subsystem is configured to receive a notification from thefirst processing subsystem, the notification comprising a determinationfrom the first processing subsystem that the BAC metric has exceeded apredetermined threshold, wherein the second processing subsystem isconfigured to trigger a transition in operation mode of at least one ofthe light emitter and vibration motor in response to notificationreceipt.
 16. The system of claim 15, wherein the transition in operationmode comprises a transition from an “off” state to an “on” state of thevibration motor.
 17. The system of claim 9, wherein the fastenercomprises a flexible polymer, the flexible polymer operable to retainthe alcohol sensor against the skin surface of the user.
 18. The systemof claim 9, wherein the alcohol sensor comprises a microporous membranepermeable to ethanol vapor and substantially impermeable to water. 19.The system of claim 9, further comprising an electrical jackelectrically coupled to the alcohol sensor, the electrical jack operableto receive an electrical power input.
 20. The system of claim 9, whereinthe alcohol sensor comprises a fuel cell.